Is NCT04897321 recruiting in Memphis, TN?

Yes, NCT04897321 is currently recruiting participants at its Memphis, TN location. This pediatric solid tumor clinical trial is actively enrolling qualified participants.

How do I join the pediatric solid tumor clinical trial in Memphis?

To join this clinical trial in Memphis, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Memphis clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Pediatric Solid Tumor Clinical Trial in Memphis, TN

About This Pediatric Solid Tumor Study in Memphis

3CAR is being done to investigate an immunotherapy for patients with solid tumors. It is a Phase I clinical trial evaluating the use of autologous T cells genetically engineered to express B7-H3-CARs for patients ≤ 21 years old, with relapsed/refractory B7-H3+ solid tumors. This study will evaluate the safety and maximum tolerated dose of B7-H3-CAR T cells.The purpose of this study is to find the maximum (highest) dose of B7-H3-CAR T cells that are safe to give to patients with B7-H3-positive solid tumors. Primary objective To determine the safety of one intravenous infusion of autologous, B7-H3-CAR T cells in patients (≤ 21 years) with recurrent/refractory B7-H3+ solid tumors after lymphodepleting chemotherapy Secondary objective To evaluate the antitumor activity of B7-H3-CAR T cells Exploratory objectives * To evaluate the tumor environment after treatment with B7-H3-CAR T cells * To assess the immunophenotype, clonal structure and endogenous repertoire of B7-H3-CAR T cells and unmodified T cells * To characterize the cytokine profile in the peripheral blood after treatment with B7-H3-CAR T cells

Sponsor: St. Jude Children's Research Hospital

Who Can Participate

Inclusion Criteria

Procurement and T-cell production eligibility\

\*a previously collected, autologous leukapheresis product can be used for T-cell production

Age ≤21 years old

B7-H3+ solid tumor with measurable disease; B7-H3 expression will be evaluated by standard immunohistochemistry (IHC) using a previously obtained biopsy; a tumor is considered B7-H3 positive with an H-score ≥100

Estimated life expectancy of \>12 weeks

Karnofsky or Lansky (age-dependent) performance score ≥50

For females of child bearing age:

Not pregnant with negative serum pregnancy test within 7 days prior to enrollment

Not lactating with intent to breastfeed

Meets eligibility criteria to undergo autologous apheresis, or have previously undergone autologous apheresis

Exclusion Criteria

Known primary immunodeficiency

Known HIV positivity

Severe intercurrent bacterial, viral or fungal infection (e.g. active hepatitis B or C infection or adenovirus infection)

History of hypersensitivity reactions to murine protein-containing products

Rapidly progressive disease (in the opinion of the study PIs) Inclusion criteria Treatment eligibility

Age ≤21 years old

B7-H3+ solid tumor with measurable disease

Evidence of relapsed or refractory disease after standard first-line therapy

Estimated life expectancy of \>8 weeks

Karnofsky or Lansky (age-dependent) performance score≥50

Echocardiogram with a ventricular ejection fraction

\>40%; or shortening fraction ≥25%

Adequate renal function defined as creatinine clearance or radioisotope GFR 50 ml/min/1.73m2 (GFR 40 ml/min/1.73m2 if \< 2 years of age)

Adequate pulmonary function defined as pulse oximetry ≥92% on room air or forced vital capacity (FVC) ≥50% of predicted value

Total Bilirubin ≤3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome

Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤5 times the upper limit of normal for age

Hemoglobin≥ 7g/dL (can be transfused)

Platelet count \>50,000/uL (can be transfused)

Absolute neutrophil count (ANC) ≥ 1000/uL

Has recovered from all NCI CTAE grade III-IV, non-hematologic acute toxicities from prior therapy

For females of child bearing age:

Not pregnant with negative serum pregnancy test within 7 days prior to enrollment

Not lactating with intent to breastfeed

If sexually active, agreement to use birth control until 3 months after T-cell infusion. Male partners should use a condom.

Available autologous transduced T-cell product that has met GMP release criteria

Agreement to participate in long-term follow-up protocol for patients, who have received genetically modified cell products Exclusion criteria

Known primary immunodeficiency

History of HIV infection

Severe, uncontrolled intercurrent bacterial, viral or fungal infection

History of hypersensitivity reactions to murine protein-containing products

Receiving systemic steroid therapy exceeding the equivalent of 0.5 mg/kg/day of methylprednisolone, in the 7 days prior to B7-H3-CAR T-cell infusion

Receiving systemic therapy in the 14 days prior to CAR T-cell infusion, which will interfere with the activity of the B7-H3-CAR product (in the opinion of the study PIs).

Rapidly progressing disease (in the opinion of the study PIs)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Memphis?

Yes, this clinical trial (NCT04897321) has an active research site in Memphis, TN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Pediatric Solid Tumor Treatment Options in Memphis, TN

If you're searching for pediatric solid tumor treatment options in Memphis, TN, this clinical trial (NCT04897321) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Memphis research site is actively enrolling participants for this clinical trial. You'll receive care from experienced pediatric solid tumor specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all pediatric solid tumor clinical trials near you to find additional studies recruiting in your area.

Pediatric Solid Tumor Clinical Trial in Memphis, TN

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